Introduction to PHRM3301

Adam La Caze

Semester 1, 2025

Objectives, Set-up and Expectations

PHRM3301 Objectives

  1. Explain the methods used to ensure rigour in the study designs employed in clinical epidemiology
  2. Evaluate the evidence provided by systematic reviews, meta-analyses, randomized trials, cohort studies and case-control studies
  3. Synthesise evidence from diverse sources to inform evidence-based decisions regarding patient care and public health (including treatment, screening, prevention and health service delivery)
  4. Identify how practitioners can make errors when reasoning about clinical evidence

  1. Develop and implement a project that takes into consideration study design, methodology, data analysis and research ethics
  2. Justify inferences from collected data by employing statistical methods
  3. Communicate insights from data as evidence within a given context for both a professional and lay audience

Course set-up

  • The course is team-taught between the School of Pharmacy and the School of Mathematics and Physics

  • PHRM3301 is a 2-unit course. You should expect to spend approximately 10 hours a week on the course
Components Hours/week (approx)
Active online learning (UQ Extend) 4–6
In-person workshops 2
Assessment 2–4

Approaching the course

Active online learning

  • Use the activities as learning activities and as feedback on how you are travelling
  • Being able to read, interpret and apply clinical research is a key objective of the course

Workshops

  • Attend in person
  • Complete the active online learning activities prior to the workshop
  • Workshops are not recorded
  • If you miss a workshop, work through the worksheet and post any questions to the discussion board

Timetable

Course Resources

Blackboard

information, assessment submission regarding the course (workshops assessment)

Course profile

information on assessment and rules.

UQ Extend

Active online learning activities

Ed Discussion Board

use Ed Discussion Board for all questions and discussion related to the course

Reading List

central reading list for course resources and RiPPLE activity

R

a free online (and powerful) statistical software environment. You will use R in the statistics component of the course. Consider getting familiar with the program prior to LW5.

Getting familiar with R early will help. See Library Resources and workshops

Expectations

  • Participate in in-person workshops and in the discussion board

  • Come to the workshops with any questions you have from the week’s learning activities

What you can expect from me

  • Clarity about learning objectives and assessment. If something is not clear post your question to the course discussion board

  • Workshops will have a worksheet. Worksheets will be on Blackboard prior to the workshop.

  • The course is set up to provide feedback and help you to progressively develop skills

Assessment

Evidence synthesis (LW1–4)

  • You will receive a published randomized trial by Week 4 and your assignment is due in Week 7.

  • The assignment is worth 30% of the grade

  • The rubric used to assess the assignment is available on Blackboard

  • Word limit 1500 words

Engagement tasks (LW5–9) (Statistics)

  • Five engagement tasks will be set over the 5 learning weeks.

  • These ongoing engagement activities occur in relation to the statistics component of the course (Learning Weeks 5–9).

  • These assessment tasks may include (but are not limited to) online quizzes and completion of problem sets related to the learning objectives in the relevant weeks.

  • Further detail is provided on Blackboard

Research Report (Statistics)

  • Identify a research question that can be answered within the “Islands” simulation.

  • Develop methods to collect and analyse the data and then present the results with conclusions.

  • This is a group inquiry-based research task (groups of up to 3 students).

  • Communicate your study design, results and conclusions in a short structured research paper.

  • The assignment is worth 30% of the grade

Written Exam

  • When: the written exam is held in the exam period at the end of the semester

  • Duration: 2 hours (10 minutes reading time)

  • Range of different question types: MCQ, multiple answer, short answer, problem solving

  • Content: is taken material throughout all of the course

  • A sample exam is available

The exam is an on-campus invigilated exam using Inspera

Grades

Assessment Due Weight
Evidence synthesis 11 April 30%
Engagement tasks (LW5–9) LW5–9 10%
Research report 26 May 30%
Written exam Exam period 30%

To pass PHRM3301 you need to achieve a total mark \(\ge\) 50%

Grade and activity data from 2024

Guidance on use of artificial intelligence

  • You are permitted to use AI in the assignments
  • Take care to know the difference between appropriate and inappropriate use
  • You need to acknowledge how you used AI and provide a link to a version of your assignment that provides a complete version history

See guidance on Blackboard and AI student hub.

Evidence-based practice review

PICO: Wagenlehner et al. (2024)

Get into a groups of 3–4.

Determine the PICO for Wagenlehner et al. (2024) based on the information provided in the abstract.1 A copy of the paper is available via Blackboard.

Make a note of any terms within the abstract that you don’t understand (especially those that are important in determining the PICO).

Participants Hospitalised adults with complicated UTI
Intervention Cefepime-tanibactorbactam IV q8h for 7 or 14 days (if bacteraemia)
Comparator Meropenem IV q8h for 7 or 14 days (if bacteraemia)
Outcome Composite of microbiologic and clinical success at 19 to 23 days in the microbiologic ITT population

Results

Provide a statement of the results of the primary endpoint.

Provide an interpretation of these results in your own words.

Composite success occurred in 207 of 293 patients (70.6%) in the cefepime–taniborbactam group and in 83 of 143 patients (58.0%) in the meropenem group. Cefepime–taniborbactam was superior to meropenem regarding the primary outcome (treatment difference, 12.6 percentage points; 95% confidence interval, 3.1 to 22.2; P = 0.009).

Argument mapping

All studies are arguments. Mapping these arguments can help you to understand and evaluate the study.

An argument map contains

  • A claim (or conclusion)
  • Reasons (that support or undermine the claim)
An example argument map

An example argument map

The following paragraph is from the introduction to Wagenlehner et al. (2024). Map out the argument for assessing cefepime-taniborbactam in a randomized trial:

Cefepime, a broad-spectrum, fourth-generation cephalosporin, is used to treat such infections [i.e. complicated UTIs].[7] Resistance to cefepime has increased with the spread of extended-spectrum \(\beta\)-lactamase (ESBL) and carbapenemase enzymes.[7,8] Taniborbactam (formerly VNRX-5133) is a bicyclic boronate \(\beta\)-lactamase inhibitor with potent, selective, direct inhibitory activity against Ambler class A, B, C, and D enzymes, including prevalent serineand metallo-\(\beta\)-lactamases.[9,10] The cefepime-taniborbactam combination is active in vitro against most isolates of carbapenem-resistant Enterobacterales species, multidrug-resistant Pseudomonas aeruginosa, and Enterobacterales species and P. aeruginosa organisms that are resistant to both ceftolozane–tazobactam and ceftazidime-avibactam.[11-14] Cefepime–taniborbactam has shown in vivo efficacy against cefepime- and carbapenem-resistant Enterobacterales species and against P. aeruginosa.[15-17] Cefepime–taniborbactam has shown an acceptable side-effect profile in healthy volunteers; both cefepime and taniborbactam have well-matched plasma pharmacokinetics with greater than 80% renal elimination.[18-20]

Use https://reasons.io/ or draw it on a page (a worked example for argument mapping is provided here).

References

Wagenlehner, Florian M., Leanne B. Gasink, Paul C. McGovern, Greg Moeck, Patrick McLeroth, MaryBeth Dorr, Aaron Dane, and Tim Henkel. 2024. “Cefepime–Taniborbactam in Complicated Urinary Tract Infection.” New England Journal of Medicine 390 (7): 611–22. https://doi.org/10.1056/NEJMoa2304748.

  1. Limiting ourselves to the abstract is often fine for a first-pass at determining the PICO. Keep in mind that it has limitations, and that once we have the first draft of the PICO we would need to read targetted sections of the paper to flesh out/confirm the key details.↩︎